title: Life-threatening dermatologic adverse events in oncology.
abstract: The incidences of life-threatening toxicities such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are inconsistently reported. The potential association of anticancer agents with SJS or TEN has not been systematically investigated. We searched the literature (Ovid: 1950 to June 2013 and PubMed: 1948 to June 2013) using terms for SJS/TEN and anticancer therapies. Primary case reports, case series, and clinical trials were included. In addition, MedWatch, the Food and Drug Administration Adverse Event Reporting System (FAERS), was searched (1968 to August 2012) for SJS/TEN reports associated with anticancer therapies. Proportional reporting ratios (PRR>2, N>3), empirical Bayes geometric mean (EBGM>2, N>3), and lower 95% confidence interval (EBGM0.05>2) were used as thresholds to constitute a signal of association between SJS/TEN and anticancer drugs. There were 46 SJS and 37 TEN cases associated with 18 and 22 anticancer drugs in the literature, respectively. Among cases in the FAERS, significant signals were associated with SJS for bendamustine and with TEN for bendamustine, busulfan, chlorambucil, fludarabine, lomustine, and procarbazine. Several drugs reported in the published literature to be associated with SJS/TEN were not found to have significant signals in FAERS. Proactive pharmacovigilance to detect and define safety signals serves to aid oncology practitioners in the recognition of possible, yet uncommon, serious, and/or life-threatening skin reactions.
authors.affiliation: aDepartment of Medicine, Dermatology Service, Memorial Sloan-Kettering Cancer Center, New York, New York bDepartment of Pharmacy Practice and Administrative Sciences, College of Pharmacy, University of New Mexico cVeterans Affairs Cooperative Studies Program, Albuquerque, New Mexico dDepartment of Dermatology eRobert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois fDepartment of Internal Medicine, Division of Dermatology, Washington University School of Medicine, St Louis, Missouri, USA.
authors.forename: Alyx C
authors.initials: AC
authors.lastname: Rosen
authors.forename: Yevgeniy
authors.initials: Y
authors.lastname: Balagula
authors.forename: Dennis W
authors.initials: DW
authors.lastname: Raisch
authors.forename: Vishvas
authors.initials: V
authors.lastname: Garg
authors.forename: Beatrice
authors.initials: B
authors.lastname: Nardone
authors.forename: Nicole
authors.initials: N
authors.lastname: Larsen
authors.forename: Jennifer
authors.initials: J
authors.lastname: Sorrell
authors.forename: Dennis P
authors.initials: DP
authors.lastname: West
authors.forename: Milan J
authors.initials: MJ
authors.lastname: Anadkat
authors.forename: Mario E
authors.initials: ME
authors.lastname: Lacouture
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects*; D006801:Humans; D013262:Stevens-Johnson Syndrome / Q000209:etiology*
chemical_list: D000970:Antineoplastic Agents